JP7262576B2 - 注射可能な長時間作用型ナルトレキソン微粒子組成物 - Google Patents

注射可能な長時間作用型ナルトレキソン微粒子組成物 Download PDF

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JP7262576B2
JP7262576B2 JP2021521011A JP2021521011A JP7262576B2 JP 7262576 B2 JP7262576 B2 JP 7262576B2 JP 2021521011 A JP2021521011 A JP 2021521011A JP 2021521011 A JP2021521011 A JP 2021521011A JP 7262576 B2 JP7262576 B2 JP 7262576B2
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naltrexone
microparticles
microparticle formulation
phase
benzyl alcohol
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JP2022511624A (ja
Inventor
ユン，グワンハム
ソウ，バンカン
デビッド オッティ，アンドリュー
パク，キナン
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チョン クン ダン ファーマシューティカル コーポレーション
パーデュー リサーチ ファウンデーション
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5146—Organic macromolecular compounds; Dendrimers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyamines, polyanhydrides
    • A61K9/5153—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Physics & Mathematics (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2021521011A 2018-10-15 2019-10-15 注射可能な長時間作用型ナルトレキソン微粒子組成物 Active JP7262576B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862745805P 2018-10-15 2018-10-15
US62/745,805 2018-10-15
PCT/KR2019/013535 WO2020080806A1 (fr) 2018-10-15 2019-10-15 Compositions injectables de microparticules de naltrexone à action prolongée

Publications (2)

Publication Number Publication Date
JP2022511624A JP2022511624A (ja) 2022-02-01
JP7262576B2 true JP7262576B2 (ja) 2023-04-21

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JP2021521011A Active JP7262576B2 (ja) 2018-10-15 2019-10-15 注射可能な長時間作用型ナルトレキソン微粒子組成物

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Country Link
US (1) US11000479B2 (fr)
EP (1) EP3866765B1 (fr)
JP (1) JP7262576B2 (fr)
KR (1) KR102639578B1 (fr)
CN (1) CN113164395A (fr)
AU (1) AU2019362730B2 (fr)
BR (1) BR112021006747A2 (fr)
CA (1) CA3112938C (fr)
FI (1) FI3866765T3 (fr)
HR (1) HRP20240356T1 (fr)
LT (1) LT3866765T (fr)
MX (1) MX2021004027A (fr)
PL (1) PL3866765T3 (fr)
PT (1) PT3866765T (fr)
RS (1) RS65300B1 (fr)
WO (1) WO2020080806A1 (fr)
ZA (1) ZA202102739B (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2022394933A1 (en) * 2021-11-18 2024-05-09 Inventage Lab Inc. Sustained-release injectable composition containing naltrexone and method for preparing same

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1415294A (zh) 2002-11-07 2003-05-07 上海医药工业研究院 一种纳曲酮长效注射微球组合物及制备方法和应用
JP2003534366A (ja) 2000-05-25 2003-11-18 アルカームズ コントロールド セラピューティクス インコーポレイテッド 改善された注射性を有する注射可能な懸濁物の調製
CN101049288A (zh) 2007-05-17 2007-10-10 中国人民解放军军事医学科学院生物工程研究所 一种提高纳曲酮微球包封率的制备新方法
CN101612437A (zh) 2009-01-09 2009-12-30 清华大学 纳曲酮微球-水凝胶骨架原位埋植给药系统
JP2011225600A (ja) 2004-04-22 2011-11-10 Alkermes Inc ナルトレキソン長時間作用性製剤および使用方法
JP2011225594A (ja) 2004-02-23 2011-11-10 Euro-Celtique Sa オピオイドアンタゴニストミクロスフェアを含有する乱用抵抗性の経皮的オピオイド送達デバイス
WO2018111851A1 (fr) 2016-12-12 2018-06-21 Phosphorex, Inc. Microparticules et nanoparticules comprenant des charges de surface négative

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US5456917A (en) * 1993-04-12 1995-10-10 Cambridge Scientific, Inc. Method for making a bioerodible material for the sustained release of a medicament and the material made from the method
US6306425B1 (en) 1999-04-09 2001-10-23 Southern Research Institute Injectable naltrexone microsphere compositions and their use in reducing consumption of heroin and alcohol
CN102871979B (zh) 2000-09-01 2014-10-22 帕尔马亚有限公司 缓释药物制剂及其施用方法
US7157102B1 (en) 2002-05-31 2007-01-02 Biotek, Inc. Multi-layered microcapsules and method of preparing same
WO2004108084A2 (fr) 2003-06-04 2004-12-16 Alkermes Controlled Therapeutics, Ii Formes polymorphes de naltrexone
CA2437639C (fr) 2003-08-11 2016-07-05 Valera Pharmaceuticals, Inc. Dispositifs de distribution de medicaments a long terme dotes de polymeres a base de polyurethane et leur fabrication
RU2390355C2 (ru) * 2004-08-12 2010-05-27 Квест Фармасьютикал Сёвисес Фармацевтические композиции для доставки с регулируемым высвобождением биологически активных соединений
CN100379420C (zh) 2006-09-19 2008-04-09 深圳市思沃生命科学技术有限公司 一种用于戒毒的长效缓释制剂及其制备方法和用途
WO2009058147A1 (fr) * 2007-10-31 2009-05-07 Celonova Biosciences, Inc. Particules polymères chargeables pour une utilisation thérapeutique dans un dysfonctionnement érectile
CN101700226A (zh) 2009-03-26 2010-05-05 海南凤凰国际药物研究院 一种不需要包衣的纳曲酮长效缓释制剂及其制备方法
KR101586789B1 (ko) 2012-12-28 2016-01-19 주식회사 종근당 양이온성 약리학적 활성물질의 서방성 지질 초기제제 및 이를 포함하는 약제학적 조성물
HRP20220922T1 (hr) 2015-08-24 2022-10-28 Rusan Pharma Limited Usadive tablete naltreksona

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Publication number Priority date Publication date Assignee Title
JP2003534366A (ja) 2000-05-25 2003-11-18 アルカームズ コントロールド セラピューティクス インコーポレイテッド 改善された注射性を有する注射可能な懸濁物の調製
CN1415294A (zh) 2002-11-07 2003-05-07 上海医药工业研究院 一种纳曲酮长效注射微球组合物及制备方法和应用
JP2011225594A (ja) 2004-02-23 2011-11-10 Euro-Celtique Sa オピオイドアンタゴニストミクロスフェアを含有する乱用抵抗性の経皮的オピオイド送達デバイス
JP2011225600A (ja) 2004-04-22 2011-11-10 Alkermes Inc ナルトレキソン長時間作用性製剤および使用方法
CN101049288A (zh) 2007-05-17 2007-10-10 中国人民解放军军事医学科学院生物工程研究所 一种提高纳曲酮微球包封率的制备新方法
CN101612437A (zh) 2009-01-09 2009-12-30 清华大学 纳曲酮微球-水凝胶骨架原位埋植给药系统
WO2018111851A1 (fr) 2016-12-12 2018-06-21 Phosphorex, Inc. Microparticules et nanoparticules comprenant des charges de surface négative

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Title
DINARVAND, R. et al，Preparation of Biodegradable Microspheres and Matrix Devices Containing Naltrexone，AAPS PharmSciTech，2003年，Vol.4(3) Article 34

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AU2019362730A1 (en) 2021-05-13
CA3112938C (fr) 2023-08-15
EP3866765A1 (fr) 2021-08-25
BR112021006747A2 (pt) 2021-07-13
EP3866765B1 (fr) 2024-02-07
FI3866765T3 (fi) 2024-04-18
RS65300B1 (sr) 2024-04-30
KR20210065190A (ko) 2021-06-03
KR102639578B1 (ko) 2024-02-21
PT3866765T (pt) 2024-04-17
CN113164395A (zh) 2021-07-23
MX2021004027A (es) 2021-08-11
PL3866765T3 (pl) 2024-06-10
AU2019362730B2 (en) 2022-10-20
US20200113835A1 (en) 2020-04-16
EP3866765A4 (fr) 2022-06-29
ZA202102739B (en) 2023-08-30
WO2020080806A1 (fr) 2020-04-23
LT3866765T (lt) 2024-04-25
HRP20240356T1 (hr) 2024-06-07
CA3112938A1 (fr) 2020-04-23
US11000479B2 (en) 2021-05-11
JP2022511624A (ja) 2022-02-01

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